International CIPN Assessment and Validation Study
- Conditions
- Chemotherapy-induced Peripheral NeuropathyQuality of Life
- Interventions
- Other: outcome measures for CIPN testing
- Registration Number
- NCT04633655
- Lead Sponsor
- University of Milano Bicocca
- Brief Summary
This is an observational study of chemotherapy-induced peripheral neurotoxicity (CIPN) patients to be investigated prospectively in order to assess responsiveness of a set of outcome measures in an international multi-center study.
- Detailed Description
The study will be performed at all participating centers and will consist of the following assessments:
Core study (assessments at baseline and at the end of treatment)
* Standard oncology assessment per local site
* NCI-CTC (national cancer institute common toxicity criteria) v.5 sensory and motor
* PRO-CTCAE (patient reported outcome-cancer common tocixity adverse event)
* PI-NRS (pain intensity numeric rating scale)
* NPS-CIN (Neuropathic Pain Scale for chemotherapy-induced neuropathy)
* EORTC CIPN20© (The European Organisation of Research and Treatment of. Cancer Quality of Life Questionnaire-CIPN twenty-item scale)
* FACT-GOG NTX v.4© (Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity)
* TNSn© (total neuropathy score, nurse version)
* PGIC (patient global impression of change)
* OXA-NQ (oxaliplatin neurotoxicity questionnaire)
Extended study (at all available sites - any combination of assessment methods is allowed, minimum at baseline and at the end of treatment)
* EORTC CIPN15
* CIPN-R-ODS (CIPN Rash overall disability scale)
* TNSc© at the same time points as for questionnaire
* OXA-NQ (also at mid-treatment)
* nerve conduction study of the radial (motor and sensory), ulnar (motor and sensory), sural, dorsal sural and common peroneal nerves (\*)
* QST (\*) \[quantitative sensory testing\]
* Serum for biomarkers search (\*)
* DN4
Rationale: Within a multi-center international collaboration among experienced neurologists, oncologists, nurses and symptom scientists, the principal aim of this study is to evaluate responsiveness of a set of outcome measures for CIPN evaluation in order to define the gold standard for its assessment.
The assessment of CIPN will be performed at different levels of investigation. The Core study will allow the evaluation of subjects with common devices, so that an assessment can be performed at any medical site (expected time for questionnaires completion 15 minutes).
The Extended study will add any combination of the listed assessment methods/biological sample collection, in order to ascertain whether this approach can provide a more careful and clinically-relevant estimate of the peripheral nervous system damage. Comparison between healthcare evaluation and subjects' report of CIPN severity using established questionnaires will be performed in both Core and Extended studies.
Aims: The primary aim for this study is to test responsiveness of the different assessment methods used in the core study, in a multi-center, multi-regional International setting, comparing changes from baseline to end of treatment. Secondary aims are:
* to evaluate responsiveness (changes from base line to end of treatment) also of the other outcome measures used in the Extended Study;
* to evaluate mid-treatment data predictiveness of end of treatment neurological status for each outcome measure;
* to evaluate recovery rate/modification of the neurological status for the follow up evaluations (3/6/12/24 months after treatment), stratifying data for different drugs.
Study Design: 1000 patients who are candidates for neurotoxic chemotherapy for any cancer with non-investigational drugs (including immune checkpoint inhibitors and "targeted" drugs) will be enrolled from participating centers. A trained investigator in each participating center will perform the selected healthcare-assessed scales and supervise the patient-completed measures as presented in Table 1. Subjects will be examined at least at baseline and end of treatment (Core Study) and at additional intermediate and follow-up timepoints (Extended study), according to their treatment plan.
Study Treatments: There are no study-specified treatments, as subjects will receive only their standard of care chemotherapy. The investigators will not influence decisions regarding treatment duration nor supply medication for this study. However, all treatment regimens will be registered.
Participating Centers minimum requirements: Participating Centers should:
1. accept the study protocol and have their participation approved by a local Ethics Committee/Institutional Review Board
2. have access through an internet connection to the secure server located at the main site
3. guarantee the proper assessment of the selected patients at least at the Core study level
4. have the potential to recruit at least 30 patients/year
5. have the capacity to upload the data collected from each patient within 1 week
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients who are receiving a neurotoxic chemotherapy outcome measures for CIPN testing List of neurotoxic drugs eligible for enrolment * Platinum drugs * Taxanes * Vinca alkaloids * Epothilones * Proteasome inhibitors * Thalidomide * Vedotin-based drugs * checkpoint inhibitors * Any combination of the aforementioned drugs
- Primary Outcome Measures
Name Time Method Chemotherapy-induced peripheral neurotoxicity as assessed by change in NCI-CTC v.5 sensory and motor grade 5 YEARS NCI-CTC v.5 sensory and motor (changes from base line to end treatment of a 0-5 score)
Chemotherapy-induced peripheral neurotoxicity as assessed by change in OXA-NQ scale 5 YEARS difference between baseline and end of treatment of chemotherapy-induced peripheral neurotoxicity as assessed by change in OXA-NQ (changes from base line to end treatment of number of symptoms: this is a yes/no questionnaire for the presence of neuropathy symptoms)
Chemotherapy-induced peripheral neurotoxicity as assessed by change in PRO-CTCAE 5 YEARS PRO-CTCAE (changes from base line to end treatment of a 0-5 score for each item)
Chemotherapy-induced peripheral neurotoxicity as assessed by change in Pain Intensity Numerical Rating Scale (PI-NRS) 5 YEARS difference between baseline and end of treatment of chemotherapy-induced peripheral neurotoxicity as assessed by change in Pain Intensity Numerical Rating Scale (PI-NRS) (0-10 score).
Chemotherapy-induced peripheral neurotoxicity as assessed by change in NPS-CIN scale 5 YEARS difference between baseline and end of treatment of chemotherapy-induced peripheral neurotoxicity as assessed by change in NPS-CIN (changes from base line to end treatment of a 0-10 score)
Chemotherapy-induced peripheral neurotoxicity as assessed by change in FACT-GOG NTX v.4© scale 5 YEARS difference between baseline and end of treatment of chemotherapy-induced peripheral neurotoxicity as assessed by change in FACT-GOG NTX v.4© (changes from base line to end treatment of a 0-44 score)
Chemotherapy-induced peripheral neurotoxicity as assessed by change in EORTC CIPN20© scale 5 YEARS difference between baseline and end of treatment of chemotherapy-induced peripheral neurotoxicity as assessed by change in EORTC CIPN20© (changes from base line to end treatment of a 0-100 score)
Chemotherapy-induced peripheral neurotoxicity as assessed by change in TNSn© scale 5 YEARS difference between baseline and end of treatment of chemotherapy-induced peripheral neurotoxicity as assessed by change in TNSn© (changes from base line to end treatment of a 0-20 score)
Chemotherapy-induced peripheral neurotoxicity as assessed by change in PGIC scale 5 YEARS difference between baseline and end of treatment of chemotherapy-induced peripheral neurotoxicity as assessed by change in PGIC (changes from base line to end treatment of a 0-10 score)
- Secondary Outcome Measures
Name Time Method Chemotherapy-induced peripheral neurotoxicity as assessed by change in neurofilament light chain (NfL) levels 7 YEARS difference between baseline and end of treatment of chemotherapy-induced peripheral neurotoxicity as assessed by change in Serum for biomarkers search: NfL dosage (pg/mL)
Chemotherapy-induced peripheral neurotoxicity as assessed by change in EORTC CIPN15 scale 7 YEARS difference between baseline and end of treatment of chemotherapy-induced peripheral neurotoxicity as assessed by change in EORTC CIPN15 (changes of the global score of this questionnaire, 0-60)
Chemotherapy-induced peripheral neurotoxicity as assessed by change in TNSc© scale 7 YEARS difference between baseline and end of treatment of chemotherapy-induced peripheral neurotoxicity as assessed by change in TNSc© (changes of the global score of this physician base scale ranging 0-48)
Chemotherapy-induced peripheral neurotoxicity as assessed by change in nerve conduction studies 7 YEARS difference between baseline and end of treatment of chemotherapy-induced peripheral neurotoxicity as assessed by change in nerve conduction study of the radial (motor and sensory), ulnar (motor and sensory), sural, dorsal sural and common peroneal nerves. Amplitude (microV for sensory and mV for motor recordings) and velocity (m/sec) will be obtained. A decrease under the normative values at all time points respect to base line will be considered as sign of neuropathy.
Chemotherapy-induced peripheral neurotoxicity as assessed by change in Quantitative sensory testing (QST) 7 YEARS difference between baseline and end of treatment of chemotherapy-induced peripheral neurotoxicity as assessed by change in QST: scores in seconds for time to pain onset and pain intensity (0=no pain; 10=worst pain
Chemotherapy-induced peripheral neurotoxicity as assessed by change in DN4 scale 7 YEARS difference between baseline and end of treatment of chemotherapy-induced peripheral neurotoxicity as assessed by change in DN4 (this is a scale ranging 0-10)
Trial Locations
- Locations (30)
Center for Molecular Medicine
🇩🇪Cologne, Germany
Northside Hospital
🇺🇸Atlanta, Georgia, United States
JHU
🇺🇸Baltimore, Maryland, United States
University of Michigan School of Nursing
🇺🇸Ann Arbor, Michigan, United States
Birmingham School of Nursing, University of Alabama
🇺🇸Birmingham, Alabama, United States
Columbia University Irving Medical Center
🇺🇸New York, New York, United States
Dept. of Neurology, Medical University of Vienna
🇦🇹Vienna, Austria
Aarhus University Hospital
🇩🇰Aarhus, Denmark
Hôpital Percy
🇫🇷Clamart, France
CHU Dupuytren
🇫🇷Limoges, France
Ospedale Valduce
🇮🇹Como, Italy
A.O.U. Policlinico "G. Martino"
🇮🇹Messina, Italy
Medical Oncoloy Unit - University of Nairobi
🇰🇪Nairobi, Kenya
The Ottawa Hospital
🇨🇦Ottawa, Canada
Cancer Center/Wexner Medical Center - Ohio State Medical Oncology Division
🇺🇸Columbus, Ohio, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, Pennsylvania, United States
University of Vermont Medical Center
🇺🇸Burlington, Vermont, United States
Brain and Mind Center
🇦🇺Sidney, Australia
International Centre for Diarrhoeal Disease Research
🇧🇩Dhaka, Bangladesh
Clínica AMO
🇧🇷Salvador, Brazil
University of Larissa
🇬🇷Larissa, Greece
"Saint Andrew's" State General Hospital
🇬🇷Patras, Greece
San Gerardo Hospital
🇮🇹Monza, Mb, Italy
Ospedale Policlinico San Martino
🇮🇹Genova, Italy
Padova Hospital
🇮🇹Padova, Italy
Azienda Ospedaliera Universitaria
🇮🇹Verona, Italy
Dong-A University - Internal Medicine Dept.
🇰🇷Busan, Korea, Republic of
Centro Hospitalar Vila Nova de Gaia/Espinho
🇵🇹Vila Nova de Gaia, Portugal
University of Basel - Department of Sport, Exercise and Health
🇨🇭Basel, Switzerland
Hospital Universitari de Bellvitge-ICO L'Hospitalet
🇪🇸Barcelona, Spain